PANSAID - PAracetamol and NSAID in combination:study protocol for a randomised trial

BACKGROUND: Effective postoperative pain management is essential for the rehabilitation of the surgical patient. No ‘gold standard’ exists after total hip arthroplasty (THA) and combinations of different nonopioid medications are used with virtually no evidence for additional analgesic efficacy compared to monotherapy. The objective of this trial is to investigate the analgesic effects and safety of paracetamol and ibuprofen alone and in combination in different dosages after THA. METHODS: PANSAID is a placebo-controlled, parallel four-group, multicentre trial with centralised computer-generated allocation sequence and allocation concealment and with varying block size and stratification by site. Blinding of assessor, investigator, caregivers, patients and statisticians. Patients are randomised to four groups: (A) paracetamol 1 g × 4 and ibuprofen 400 mg × 4, (B) paracetamol 1 g × 4 and placebo, (C) placebo and ibuprofen 400 mg × 4 and (D) paracetamol 0.5 g × 4 and ibuprofen 200 mg. The two co-primary outcomes are 24-h consumption of morphine and number of patients with one or more serious adverse events within 90 days after surgery. Secondary outcomes are pain scores during mobilisation and at rest at 6 and 24 h postoperatively, and number of patients with one or more adverse events within 24 h postoperatively. Inclusion criteria are patients scheduled for unilateral, primary THA; age above 18 years; ASA status 1–3; BMI >18 and <40 kg/m(2); women must not be pregnant; and provision of informed consent. Exclusion criteria are patients who cannot cooperate with the trial; participation in another trial; patients who cannot understand/speak Danish; daily use of strong opioids; allergy against trial medication; contraindications against ibuprofen; alcohol and/or drug abuse. A total of 556 eligible patients are needed to detect a difference of 10 mg morphine i.v. the first 24 h postoperatively with a standard deviation of 20 mg and a family wise type 1 error rate of 0.025 (two-sided) and a type 2 error rate of 0.10 for the six possible comparisons of the four intervention groups. DISCUSSION: We started recruiting patients in December 2015 and expect to finish in September 2017. Data analysis will be from September 2017 to October 2017 and manuscript submission ultimo 2017. TRIAL REGISTRATION: EudraCT: 2015-002239-16 (12/8-15); ClinicalTrials.gov: NCT02571361. Registered on 7 October 2015. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-016-1749-7) contains supplementary material, which is available to authorized users

Nu-DESC DK: the Danish version of the nursing delirium screening scale (nu-DESC)

Abstract Background Delirium is one of the most common complications among elderly hospitalized patients, postoperative patients and patients on intensive care units with a prevalence between 11 and 80%. Delirium is associated with higher morbidity and mortality. Reliable instruments are required to detect delirium at an early time point. The Nursing-Delirium Screening Scale (Nu-DESC) is a screening tool with high sensitivity and good specificity. However, there is currently no official translation after ISPOR guidelines of any Danish delirium assessment tools available. Thereby hampering the implementation of 2017 ESA-Guidelines on postoperative Delirium in the clinical routine. The aim of this study is to provide an official translation and evaluation of the Nu-DESC into Danish following the ISPOR process. Methods The Nu-DESC was translated after International Society for Pharmacoecomonics and Outcome Research (ISPOR) guidelines to Danish after permission of the original author, and is evaluated by medical staff and finally approved by the original author. Results All steps of the ISPOR guideline were consecutively followed, without any major problems. The evaluation of the Nu-DESC DK regarding its intelligibility and feasibility showed no statistically significant differences between nurses and medical doctors ratings. The translation was authorized and approved by the original author. Conclusion This study provides the Nu-DESC DK, an official Danish delirium screening instrument, which can detect all psychomotor types of delirium

Association between using a prehospital assessment unit and hospital admission and mortality: a matched cohort study

Objectives This study aimed to compare hospital admission and 30-day mortality between patients assessed by the prehospital assessment unit (PAU) and patients not assessed by the PAU.Design This was a matched cohort study.Setting This study was conducted between November 2021 and October 2022 in Region Zealand, Denmark.Participants 989 patients aged &gt;18, assessed by the PAU, were identified, and 9860 patients not assessed by the PAU were selected from the emergency calls using exposure density sampling.Exposure Patients assessed by the PAU. The PAU is operated by paramedics with access to point-of-care test facilities. The PAU is an alternative response vehicle without the capability of transporting patients.Primary and secondary outcome measures The primary outcome was hospital admission within 48 hours after the initial call. The key secondary outcomes were admission within 7 days, 30-day mortality and admission within 6 hours. Descriptive statistical analyses were conducted, and logistic regression models were used to estimate adjusted OR (aOR) and 95% CI.Results Among the PAU assessed, 44.1% were admitted within 48 hours, compared with 72.9% of the non-PAU assessed, p&lt;0.001. The multivariable analysis showed a lower risk of admission within 48 hours and 7 days among the PAU patients, aOR 0.31 (95% CI 0.26 to 0.38) and aOR 0.50 (95% CI 0.38 to 0.64), respectively. The 30-day mortality rate was 3.8% in the PAU-assessed patients vs 5.5% in the non-PAU-assessed patients, p=0.03. In the multivariable analysis, no significant difference was found in mortality aOR 0.99 (95% CI 0.71 to 1.42). No deaths were observed in PAU-assessed patients without subsequent follow-up.Conclusion The recently introduced PAU aims for patient-centred emergency care. The PAU-assessed patients had reduced admissions within 48 hours and 7 days after the initial call. Study findings indicate that the PAU is safe since we identified no significant differences in 30-day mortality.Trial registration number NCT05654909

Effect of dexamethasone on intraoperative remifentanil dose in total knee arthroplasty surgery under general anaesthesia.

BACKGROUND: The effects of glucocorticoids may include both genomic and rapid nongenomic effects. The potential rapid analgesic effect during surgery has not previously been investigated. We aimed to explore the effect of dexamethasone on intraoperative infusion rate of remifentanil in patients undergoing total knee arthroplasty (TKA) surgery under general anaesthesia. METHODS: In this post hoc subgroup analysis, we included patients randomised in the DEX‐2‐TKA trial, who were operated under total intravenous anaesthesia with remifentanil and propofol. Trial medication, intravenous dexamethasone 24 mg or placebo, was administered immediately after anaesthesia onset. The primary outcome was the median weight‐corrected infusion rate of remifentanil during surgery. Secondary outcomes included median weight‐corrected infusion rate of propofol, median intraoperative bispectral index and time spent in the post‐anaesthesia care unit. RESULTS: Eighty‐seven patients were included in the analysis of the primary outcome. A significantly higher remifentanil infusion rate was observed in the dexamethasone group compared with the placebo group, p = .02. None of the secondary outcomes resulted in statistically significant differences between groups. CONCLUSION: This explorative post hoc analysis of the randomised DEX‐2‐TKA trail showed that patients undergoing TKA surgery under general anaesthesia and who received dexamethasone seemed to have a higher remifentanil infusion rate compared with patients who received placebo. The clinical implications of the potentially increased remifentanil infusion rate need to be validated and explored further. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05002361 (12 August 2021)